Planning and Evaluation of Bioequivalence Studies of Enalapril Products-Reference-Cited by-同舟云学术

Planning and Evaluation of Bioequivalence Studies of Enalapril Products

Published:2018-12-20 Issue:4 Volume:8 Page:231-237
ISSN:2619-1172
Container-title:The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products
language:
Short-container-title:Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya

Author:

Romodanovsk D. P.¹^ORCID,Khokhlov A. L.²^ORCID,Miroshnikov A. E.²^ORCID

Affiliation:

1. Scientific Centre for Expert Evaluation of Medicinal Products

2. Yaroslavl State Medical University

Publisher

SCEEMP

Reference8 articles.

1. Romodanovskii DP, Dranitsyna MA, Goryachev DV, Niyazov RR, Gavrishina EV. Planirovanie dizaina i otsenka rezul'tatov issledovanii bioekvivalentnosti vysokovariabel'nykh preparatov na primere rozuvastatina. Eksperimental'naya i klinicheskaya farmakologiya. 2015;78(6):19–25. [Romodanovsky DP, Dranitsyna MA, Goryachev DV, Niyazov RR, Gavrishina EV. Design planning and evaluation of the results of bioequivalence studies of highly variable drugs using rosuvastatin as an example. Eksperimentalnaya i klinicheskaya farmakologiya=Experimental and Clinical Pharmacology. 2015;78(6):19–25 (In Russ.)] https://doi.org/10.30906/0869-2092-2015-78-6-19-25

2. Romodanovskii DP, Eremenkova TV, Dranitsyna MA, Goryachev DV, Niyazov RR, Gavrishina EV, Merkulov VA. Vysokovariabel'nye lekarstvennye preparaty – osobennosti issledovaniya bioekvivalentnosti. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya. 2015;(4):5–10. [Romodanovsky DP, Eremenkova TV, Dranitsyna MA, Goryachev DV, Niyazov RR, Gavrishina EV, Merkulov VA. Highly variable medicines – specific aspects of bioequivalence studies. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya=The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(4):5–10 (In Russ.)]

3. Davit BM, Conner DP, Fabian-Fritsch B, Haidar SH, Jiang X, Patel DT, et al. Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications. AAPS J. 2008;10(1):148–56. https://doi.org/10.1208/s12248-008-9015-x

4. Davit BM, Chen ML, Conner DP, Haidar SH, Kim S, Lee CH, et al. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration. AAPS J. 2012;14(4):915–24. https://doi.org/10.1208/s12248-012-9406-x

5. Tothfalusi L, Endrenyi L, Arieta AG. Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence. Clin Pharmacokinet. 2009;48:725–43. https://doi.org/10.2165/11318040-000000000-00000.